Quality Technician II

Provides technical assistance to engineering to support product development (Axonics) and manufacturing efforts by implementing corrective and preventative actions and managing nonconforming product. Assists engineers in developing methods and procedures to establish, control and improve manufacturing processes. Assists Quality Engineering and cross-functional teams in supporting process development during new product introduction by providing input to traceability and inspection requirements, providing input for statistical process control criteria, developing manufacturing instructions, and creating training sheets and certifications. Uses analytical skills, technical knowledge and procedures / processes to problem solve; evaluates, selects and implement the most appropriate solutions from options determined. Helps to develop and implement process improvements by assisting Engineering in researching and validating changes in processes/equipment. Develop, monitor, and report on key quality metrics and performance indicators to identify trends, drive decision-making, and support strategic planning. Assists Engineering with qualification and validation studies & reports by collecting, compiling, measuring, organizing and recording data, and by writing procedures. May keep ELNs. Train operators on processes and engineering changes, and perform operator certification on-the-job training and Quality Defect Awareness (QDA) roll out. Responsible for the final Process Monitor Release for products prior to distribution. Disposition non-conforming material by utilizing quality tools and by developing knowledge of manufacturing practices and procedures. Conducts audits of manufacturing and related areas to assess compliance with internal procedures; reviews finding to determine compliance risk and systems issues. Prepare and administer reports of audit findings. Assists engineering in providing day to day manufacturing process support by identifying manufacturing issues and trends. May also train operators on basic processes and engineering changes, and perform operator certification on-the-job training and Quality Defect Awareness (QDA) roll out. Involved with NCEPs, CAPAs and Work Station Vulnerability Assessments (WSVAs). NFQ Higher certificate Level 6 in Engineering Studies, Science, Quality Management or a related subject is required. Minimum 2 - 5 years medical device experience required. Ability to manage multiple projects and priorities simultaneously, demonstrating strong organizational skills, attention to detail, and the ability to deliver results within tight timelines is a distinct advantage. Experience with product development initiatives and familiarity with Windchill is a distinct advantage. Demonstrated analytical, communication, attention to detail and organizational skills is a distinct advantage. Passionate about quality, innovation, and delivering products that improve patient outcomes.